Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05306912

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

Led by University Hospital, Toulouse · Updated on 2026-04-29

60

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool. Complementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (\<3% complications) but of limited sensitivity in cases of nodules \< 20 mm. The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity

CONDITIONS

Official Title

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • rEBUS bronchoscopy planned for one, two or three nodules 20 mm or smaller
  • World Health Organization (WHO) Performance status 0-3
  • Signed informed consent
  • Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage)
Not Eligible

You will not qualify if you...

  • Lung cancer diagnosed before the date of the procedure
  • Lung cancer strongly suspected due to mediastinal or extra thoracic lesions
  • Patient under State Medical Assistance
  • Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice

AI-Screening

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Trial Site Locations

Total: 1 location

1

Toulouse University Hospital

Toulouse, Occitanie, France, 31300

Actively Recruiting

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Research Team

V

Valentin HELUAIN, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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